Today, the U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China and announcing expanded actions for Jiangsu Shenli Medical Production Co. Ltd. with an additional import alert for not meeting device quality system requirements, to prevent all plastic syringes by this manufacturer from entering the United States.
We are also providing an update to our recommendations:
- Until further notice and because of potential quality and performance issues, the agency recommends that U.S. suppliers of plastic syringes, consumers, health care providers and facilities immediately transition away from using all models of plastic syringes (including 5 mL luer lock syringes) manufactured by Jiangsu Shenli Medical Production Co Ltd, unless use of these syringes is absolutely necessary until you can complete the transition.
We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and continue to have recommendations for U.S. suppliers of plastic syringes, consumers, health care providers and facilities. We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.